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The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept Treatment A | Experimental |
| |
| Abatacept Treatment B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) | Up to Day 71 | |
| Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T)) | Up to Day 71 | |
| Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF)) | Up to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to Month 12 | |
| Number of participants with clinical laboratory abnormalities | Up to Month 12 | |
| Number of participants with vital sign abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Cypress | California | 90630 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Up to Month 12 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 71 |
| Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours)) | Up to Day 71 |
| Serum concentration at 168 hours after dosing (C168) | Up to Day 71 |
| Time of maximum observed serum concentration (Tmax) | Up to Day 71 |
| Number of laboratory-reported positive responses of anti-abatacept antibodies | Up to Month 12 |
| Number of laboratory-reported positive responses of anti-CTLA4-T antibodies | Up to Day 71 |
| Miami |
| Florida |
| 33147 |
| United States |
| Local Institution | Las Vegas | Nevada | 89113 | United States |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |